September 26, 2022
UL Solutions has reached a milestone of 500 million e-learning and training completions via the ComplianceWire® learning management system (LMS) for life science companies, indicating the outsized role the platform plays when it comes to supporting stakeholders’ training- and compliance-related needs.
ComplianceWire® LMS features a globally recognized, comprehensive software as a service (SaaS) training platform to support companies in the pharmaceutical, medical device and biologics sectors in their regulatory compliance and employee education efforts. Furthermore, ComplianceWire® was the first cloud-based life sciences LMS to comply with FDA 21 CFR part 11/EU Annex 11 requirements covering the scope and application of electronic records and signatures as well as computer system validation requirements, and now assists users with their own Part 11 validation and compliance efforts.
U.S. FDA’s role in driving LMS usage
ComplianceWire® currently has 3.6 million users across more than 600 organizations in the pharmaceutical, medical device and biologics sectors in 153 countries — but also counts regulatory agencies in the U.S., Brazil, China and India as users. Indeed, a key factor in the LMS’s steady adoption rate across life sciences is the yearslong collaboration between ComplianceWire® and the U.S. Food and Drug Administration (FDA) via a cooperative research and development agreement (CRADA).
Since the CRADA was first established in 1999, the FDA has relied on ComplianceWire® to train more than 40,000 federal, state and local regulatory investigators. Under the CRADA, UL Solutions and the FDA have developed a library of over 100 life sciences eLearning courses. The same best-of-breed LMS technology platform and unique training coursework developed under the CRADA for FDA inspectors is available to ComplianceWire® life science industry customers, which has helped spur the half-billion eLearning and training completions thus far.
“These 500 million LMS completions reflect our successful, ongoing collaboration with the U.S. FDA,” Jim O’Keefe, director and general manager at UL Solutions ComplianceWire®, said. “UL Solutions is very proud that we are able to contribute to the safety and compliance of the global life sciences industry as part of our greater mission of working for a safer world.”